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Department of Otolaryngology
University of Iowa
First Published: 2000
Last Revised: October 2003
Peer Review Status: Internally Peer Reviewed
Who is a candidate?
Cochlear implants are medical devices regulated by the FDA. Each new
device must undergo clinical investigation at a limited number of cochlear
implant clinics before approved for general use. In general, whether a
device is approved or still under investigation makes a difference as
to who is a candidate to receive the implant, how frequently return visits
to the clinic are required, and how much is known about the safety and
benefits of a particular device. Two of the devices we offer currently,
the Nucleus 24M and the Clarion CII HF1, have received FDA approval. The
third, the Clarion CII HF II, is an investigational device.
Although age at onset of deafness in adults
does not affect the outcome, the earlier a
person receives an implant following deafness,
the greatest the likelihood of benefit.
Criteria for Adults
- 18 years or older
- Bilateral severe-to-profound sensorineural hearing loss
- Minimal benefit from appropriate hearing aids (preop HINT sentence
recognition scores of < or = to 50% in the best aided sound-only
condition)
- Postlingual deafness in ear to be implanted
- English as primary language
- Ability and willingness to comply with all study requirements as described
in the informed consent documents
- Willingness to participate in future studies conducted by sponsor
and investigator and approved by FDA to evaluate these devices.
Criteria for Children
- 12 months to 17 years old,
- Profoundly deaf and unable to benefit from appropriate conventional
amplification
- Cooperative enough to undergo the testing required and then willing
to wear the external apparatus
- Educational setting with a strong auditory component.
Parents of children who receive cochlear implants must appreciate the
considerable time commitment involved. They must agree to return with
the child to the implant center for follow-up testing and monitoring of
the cochlear implant. The parents also must be willing to cooperate and
work with the child’s educators to provide appropriate habilitation.
The Implant Operation
Cochlear implants are placed under the skin in the
temporal area and the electrodes are inserted into the
cochlea using a routine surgical procedure. A miniature cord
connects the headpiece at the ear with the speech processor,
and the speech processor with the transmitting coil. The
speech processor is worn by the patients, as they find
convenient.
The operation to implant this device takes about 3 hours and is done
under general anesthesia. The patient checks in on the day of surgery,
stays overnight in the hospital and typically is discharged the next day.
Costs
At this time costs of the implant device and operation, including most
follow-up visits for the first three months postoperatively, may total
from $40,000 to $50,000, depending on a number of medical and nonmedical
factors. These costs are the responsibility of the patient’s family
and their health insurance plan or other third party payor. The implant
devices are usually warrantied for a period of three years, but thereafter
maintenance of the device is the responsibility of the user. Purchase
of maintenance contracts from the manufacturer is strongly advised (currently
these contracts are priced at around $300-400/year).
Some insurance contracts will cover a majority of the costs of implantation.
Medicaid may cover a smaller portion; but in both cases it is necessary
to obtain prior approval of benefits. Medicare will cover a portion of
the costs and supplementary contracts, an additional portion beyond Medicare
payments. Probably under the best of circumstances your payment responsibility
will average a minimum of 20% to 30% of charges approved by your insurance
plan.
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